MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Dislocation (2374); Subluxation (4525); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref (b)(4), lot 62010688 head; ref (b)(4), lot 61954092 shell; ref (b)(4), lot 61871871 durasul liner.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip revision approximately 6 years post implantation due to pain, recurrent dislocations, instability, and elevated metal ions.During the revision, a large pseudocapsule, trunnionosis, and extensive tissue damage with altr and necrosis was encountered.The shell and stem were left intact.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records confirmed that the patient was revised to address pain, recurrent dislocations, instability, trunnionosis, pseudocapsule, elevated metal ions, extensive tissue damage and necrosis.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: h6 proposed component code: mechanical (g04)-stem.Review of complaint history identified additional similar complaints for the head and stem, no complaints for the liner, and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Root cause unchanged, if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

There is no update to the prior event description provided.

• Brand Name: FEMORAL STEM 12/14 NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12555329
• MDR Text Key: 274054497
• Report Number: 0001822565-2021-02757
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00771101210
• Device Lot Number: 61937572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female